Drug delivery system including holder and drug container

ABSTRACT

A drug delivery system for administering preset doses of a substance such as a drug, vaccine or the like is provided. The drug delivery system includes a holder and a pre-filled drug container such as a syringe which is securely retained in the holder. The drug container includes a barrel for containing the substance, a movable stopper situated within the barrel, and a blunt end having an opening through which the substance within the barrel can be expelled. The holder includes a distal portion and a proximal portion, each configured to accommodate the drug container, with the distal portion being able to be assembled to the proximal portion, which acts as a plunger rod during activation of the delivery system. A plurality of slots are provided for controlling the delivery of a substance and extend axially along at least one portion of the holder whereby upon activation of the system, the portions of the holder move towards one another upon the application of a minimum force and the stopper moves a preselected axial distance to expel at least a portion of the substance from the drug container. One application is to a nasal drug container, where approximately equal doses of the substance are desired to be administered to each nostril of the patient.

This is a continuation of application Ser. No. 09/417,346, filed Nov.14, 1999, now U.S. Pat. No. 6,382,204.

FIELD OF THE INVENTION

The present invention generally relates to delivery systems fordelivering substances such as drugs, vaccines and the like, and morespecifically relates to a drug delivery device for preferably deliveringsuch substances intranasally, i.e., through the nose, including a holderand a prefilled drug container such as a syringe. In addition, thepresent invention relates to a holder for use by one hand in which thetravel of the stopper is controlled to insure tile application of aminimum force before activation and to divide the substance to bedelivered into at least two doses.

BACKGROUND OF THE INVENTION

A number of medications may be effectively administered through thenasal passages. Devices have accordingly been developed for this purposeincluding either cartridges, such as those described in U.S. Pat. No.5,893,484 (Fuchs et al.), U.S. Pat. No. 5,813,570 (Fuchs et al.), U.S.Pat. No. 5,655,689 (Fuchs et al.), U.S. Pat. No. 5,511,698 (Solignac),U.S. Pat. No. 5,427,280 (Fuchs), U.S. Pat. No. 5,289,818 (Citterio etal.), U.S. Pat. No. 5,284,132 (Geier) and U.S. Pat. No. 5,171,219(Fujioka et al.), or syringes, such as those described in U.S. Pat. No.5,601,077 (Imbert), U.S. Pat. No. 4,923,448 (Ennis, III), U.S. Pat. No.4,767,416 (Wolf et al.) and U.S. Pat. No. 4,344,573 (De Felice).

The nasal syringes are usually of a more conventional construction suchas that described in U.S. Pat. No. 5,601,077 (Imbert) which includes acylindrical barrel having a blunt tip portion for insertion into anostril. A stopper is positioned within the barrel. A plunger extendsfrom the end of the barrel opposite to the blunt tip. The plungercontrols the position of the stopper within the barrel. A flange may beprovided on one end of the plunger to facilitate its use. However,limitations remain, particularly with respect to insuring thatsufficient force is applied to the plunger to obtain a therapeuticeffective spray.

Nasal syringes are often supplied to users pre-filled with medication.Whether pre-filled or not, it may be desirable to administer selected,and usually equal volumes of medication to each nostril. U.S. Pat. No.4,962,868 (Borchard) discloses the use of a telescoping tube assemblywhich is designed for expelling the contents of a nasal syringe in twocontrolled doses. Also, U.S. Pat. No. 5,601,077 (Imbert) discloses theuse of a dose limited in the form of a c-shaped attachment on theplunger rod for limiting movement in the distal directed so thatapproximately half of the substance to be delivered remains in thesyringe. To continue, the user simply removes the attachment from theplunger rod. In addition, U.S. Pat. No. 5,951,526 (Korisch et al.)discloses a holder having an integral dose divider. However, it remainsdifficult for users to administer equal doses of medication to eachnostril, especially with one hand.

Accordingly, there has been a need for a nasal drug delivery devicewhich over comes the problems and limitations associated with the use ofthe prior devices for delivering a substance, especially intranasallyeasily with one hand, including delivery of a uniform spray which can bedivided into at least two separate doses for delivery into each nostril.Also, there has been a need for a device which would permit the user toobserve the substance in the device to determine, for example, if thedevice has been previously used.

SUMMARY OF THE INVENTION

In contrast to the prior devices discussed above, it has been found thata drug delivery device particularly suited for use in intranasallydelivering substances such as drugs, vaccines and the like can beconstructed in accordance with the present invention. Specifically, theinvention is directed to an assembly such as a housing which allows theuse of a conventional, pre-filled drug containers such as syringe whileproviding control of the dose to be administered. The assembly isparticularly applicable to nasal syringes where it is often desirable todispense medication in two equal doses.

The system of the present invention for delivering at least onesubstance in at least two doses includes a drug container including abarrel, a first end extending from the barrel, and a stopper slidablypositioned within the barrel, a holder having a distal portion and aproximal portion, with the distal portion being assembled to theproximal portion, with the drug container secured therein, and means forcontrolling the delivery of a substance contained in the barrel of thedrug container including a plurality of slots extending axially along atleast one of the portions of the holder whereby upon activation of thesystem, the portions of the holder move towards one another upon theapplication of a minimum force and the stopper moves a preselected axialdistance to expel at least a portion of the substance from the drugcontainer.

In the preferred embodiment of the system, the first end of the drugcontainer includes a spray nozzle for use in intranasally delivering thesubstance and the drug container is a syringe, and the distal portion ofthe holder acts as a plunger rod during activation of the system. Inaddition, the distal portion and the proximal portion of the holder eachhas a generally tubular interior configured to accommodate the drugcontainer filled with a substance to be delivered and the proximalportion of the holder includes a closed end having a rod extendingtherefrom for engagement with the stopper of the drug container uponactivation. Also, the preselected axial distance corresponds to about adosage of the substance held in the drug container barrel desired to beadministered in a first motion of the stopper, with the preselectedaxial distance preferably corresponding to about half the distance thatthe stopper is capable of moving within the barrel to administer abouthalf of the substance held by the drug container.

In addition the preferred system of the present invention includes ameans for securing the drug container in the distal portion of theholder with the distal portion having a first end through which thefirst end of the drug container can extend and a second, open enddefining an opening of sufficient size for receiving the drug container.Specifically, the drug container is preferably a syringe having a rimextending from an open end thereof and the drug container securing meansis situated adjacent the open end of the distal portion and includes atleast one detent situated adjacent the open end and dimensioned so thatthe rim of the syringe may be securely retained in the distal portion bythe detent. Also, a pair of flanges extend radially outwardly from thedistal portion of the holder and attached thereto by a plurality ofribs, and the distal portion of the holder includes at least one windowto permit visual inspect of the contents of the drug container locatedwithin the holder.

Further, the distal portion includes at least one pair of ribs andwherein the slots in the proximal portion of the holder include at leastone pair of slots situated thereof, with the pair of slots including afirst slot and a second slot extending axially along the body of theproximal portion of the holder generally parallel to each other anddimensioned and situated to accommodate the ribs so that one of the ribsis insertable into each slot and able to travel along the slot uponactivation of the system. Also, the first slot is preferably open and isdivided into at least two portions, and situated adjacent an open end ofthe first slot is a bridge extending across at least a portion of theslot, with the bridge being dimensioned so that when a rib comes incontact with the bridge and sufficient force is applied there against,the bridge will fracture to allow passage of the rib alone the slot. Inaddition, a detent is situated adjacent the open end of the firstportion of the first slot so that the rib can be clipped between thedetent and the bridge prior to activation of the system, and the secondportion of the first slot is at least slightly offset from the firstportion of the first slot and towards the second slot, and the other ribtravels along the second slot to provide structural stability andtracking, with the second slot including biasing means for biasing therib in the first slot towards the second portion of the slot uponrelease of the force applied by a user. The biasing means is adapted toinclude a cut-away portion forming a deflectable arm having an innerwall associated with the second slot so that as the ribs travel alongtheir respective slots, the one rib will deflect the flexible arm tocause the proximal portion of the holder to rotate relative to thedistal portion about a central axis so that the rib situated in thefirst slot can come in contact with a second bridge so that uponsufficient force being applied, the bridge will fracture to allowpassage of the rib along the second portion of the first slot.

The holder of the present invention includes a distal portion and aproximal portion, each configured to accommodate a drug container filledwith a substance to be delivered, with the distal portion being able tobe assembled to the proximal portion, and means for controlling thedelivery of the substance including a plurality of slots extendingaxially along at least one of the portions of the holder whereby whenthe portions of the holder are moved towards one another upon theapplication of a minimum force, at least a portion of the substance canbe expelled from the drug container.

In the preferred embodiment of the holder, a first end of the drugcontainer includes a spray nozzle and the drug container is a syringe,and the distal portion and the proximal portion each has a generallytubular interior configured to accommodate the syringe and the proximalportion of the holder includes a closed end having a rod extendingtherefrom for engagement with the stopper of the syringe duringactivation.

The system of the present invention for the nasal delivery of at leastone substance includes a syringe having a barrel, a first end extendingfrom the barrel, the first end including a spray nozzle having anopening for dispensing the substance from the barrel, and at least onestopper slidably positioned within the barrel, a holder having a distalportion and a proximal portion, each configured to accommodate thesyringe, with the distal portion being able to be assembled to theproximal portion, which acts as a plunger rod during activation of thesystem, and means for controlling the delivery of a substance includinga plurality of slots extending axially along at least one of theportions of the holder whereby upon activation of the system, theportions of the holder move towards one another upon the application ofa minimum force and the stopper moves a preselected axial distance toexpel at least a portion of the substance from the syringe, with thepreselected axial distance corresponding to about half the distance thatthe stopper is capable of moving within the barrel to administer abouthalf of the substance contained by the syringe barrel.

In the preferred embodiment of the system, a pair of flanges extendradially outwardly from the distal portion of the holder and areattached there along by a plurality of ribs, and the distal portion andthe proximal portion each have a generally tubular configuration. Inaddition, the slots in the proximal portion of the holder include twocorresponding sets situated on each side thereof with each set includinga first slot and a second slot extending axially along the body of theproximal portion of the holder generally parallel to each other anddimensioned and situated to accommodate the ribs so that the ribs areinsertable into the slots and able to travel along the slots uponactivation of the system, and the first slot is preferably open and isdivided into at least two portions, and situated adjacent an open end ofthe first slot is a bridge extending across at least a portion of theslot, with the bridge being dimensioned so that when a rib comes incontact with the bridge and sufficient force is applied there against,the bridge will fracture or deform to allow passage of the rib along theslot. In addition, a detent is situated adjacent the open end of thefirst portion of the first slot so that the rib can be clipped betweenthe detent and the bridge prior to activation of the system and thesecond portion of the first slot is at least slightly offset from thefirst portion of the first slot and towards the second slot. One of theribs travels along each of the second slots to provide structuralstability and tracking, with each second slot including a cut-awayportion forming a deflectable arm for biasing the ribs in the firstslots towards the second portions of the slots upon release of the forceapplied by a user so that as the ribs travel along their respectiveslots, the ribs traveling along the second slots will deflect theflexible arms to cause the proximal portion of the holder to rotaterelative to the distal portion about a central axis so that the ribssituated in the first slots each come in contact with a second bridge sothat upon sufficient force being applied, the bridges will each fractureor deform to allow passage of the ribs along the second portions of thefirst slots.

The method of the present invention for intranasally delivering at leastone substance in at least two doses, includes the steps of grasping apre-assembled drug delivery system with a thumb and two forefingers ofone hand, said drug delivery system including a drug container and aholder, with the drug container including a barrel, a first endextending from the barrel, and a stopper slidably positioned within thebarrel and the holder having a distal portion and a proximal portion,with the distal portion being assembled to the proximal portion, withthe drug container secured therein, and the proximal portion acting as aplunger rod during activation of the system, inserting the end of thedrug container into one nostril of a person to whom the substance is tobe intranasally delivered, squeezing together the thumb and twoforefingers of one hand to apply sufficient force to overcome a bridgeextending at least partially across a slot to insure the application ofa minimum force, moving the proximal portion of the holder towards thedistal portion of the holder a first predetermined distance during afirst motion as a result of continuing to squeeze together the thumb andtwo forefingers to cause the displacement of the stopper and expulsionof a first predetermined amount of a substance contained in the chamberof the drug container barrel into the nostril, removing the end of thedrug container from the nostril while relaxing the squeezing force beingapplied and inserting the end of the drug container into another nostrilof the person to whom the substance is to be intranasally delivered,squeezing together the thumb and two forefingers to apply sufficientforce to overcome a second bridge extending at least partially acrossthe slot to insure the application of a minimum force, and moving theproximal portion of the holder towards the distal portion of the holdera second predetermined distance during a second motion as a result ofcontinuing to squeeze together the thumb and two forefingers to causethe displacement of the stopper and expulsion of a second predeterminedamount of the substance contained in the chamber of the drug containerbarrel into the other nostril.

In the preferred embodiment of the method, the first predetermineddistance is approximately equal to the second predetermined distance andthe first predetermined amount of substance expelled is approximatelyequal to the second predetermined amount of substance expelled. Also,the method includes the step of visually inspecting the contents of thedrug container located within the holder through at least one windowlocated in the distal portion of the holder. In addition, relaxing theforce being applied during the first motion causes the proximal portionof the holder to rotate about its axis by a force exerted by biasingmeans. Further, the method includes the step of removing a tip cap fromthe end of the drug container. The step of grasping the drug deliverydevice includes placing each of the two forefingers on a flangeextending from the distal portion and placing the thumb on a closed endof the proximal portion.

BRIEF DESCRIPTION OF THE DRAWINGS

The various features, objects, benefits, and advantages of the presentinvention will become more apparent upon reading the following detaileddescription of the preferred embodiment along with the appended claimsin conjunction with the drawings, wherein like reference numeralsidentify corresponding components, and:

FIG. 1 is an exploded, perspective view of the holder and syringe of thedrug delivery system of the present invention;

FIG. 2 is a top perspective view of the assembled drug delivery system;

FIG. 3 is a side view of the two portions of the holder prior toassembly;

FIG. 4 is top view of the two portions of the holder prior to assembly;

FIGS. 5-9 are various side views of the holder showing the two portionsassembled at various stages of activation to deliver doses of thesubstance contained therein;

FIGS. 10-12 are various top, sectional views of the syringe and holderat various stages during activation of the drug delivery system showingthe position of the plunger within the syringe;

FIGS. 13 and 14 are schematic representations of the drug deliverydevice of the present invention being used to deliver the substance toeach of the nostrils of the user; and

FIG. 15 is a fragmentary, sectional view of an alternative embodiment ofthe drug delivery system illustrating securement of the syringe in theholder.

DETAILED DESCRIPTION OF THE INVENTION

The drug delivery system of the present invention is illustrated inFIGS. 1-15, and generally includes the designation 20. Referring toFIGS. 1 and 2, the system 20 of the present invention includes a drugcontainer such as preferably a syringe 22 and a holder 24. When used todelivery substances intranasally, the assembly insures that thesubstance to be delivered by the syringe is sprayed into the nostril andcan be divided into at least two doses. It further limits thepenetration of the syringe tip into the nostril and permits visualinspection of the substance contained in the system.

Referring to FIGS. 1 and 2, the holder 24 for the syringe is comprisedof at least two portions, i.e., a distal portion 26 and a proximalportion 28, each have a generally tubular interior configuration toaccommodate the syringe 22 therein. For the purposes of the descriptionof the present invention, the term “distal” is meant to refer to theportion or end furthest from the person holding the system of thepresent invention and the term “proximal” is meant to refer to theportion or end closest to the person holding the system.

The particular syringe of the system is not essential to the presentinvention and may include, for example, when used to delivery substancesintranasally, the nasal syringe disclosed in U.S. Pat. No. 5,601,077(Imbert), the disclosure of which is hereby incorporated by reference inits entirety. However, preferably, the syringe 22 includes an elongatedcylindrical barrel 30 made of either glass or plastic having an openproximal end 32, a chamber 34 for retaining the substance to bedelivered and a distal end or tip 36, with the chamber 34 extending fromthe proximal end to the distal end 36. The distal end includes anorifice 37 through which the substance can be expelled from the chamber.In the preferred embodiment, the proximal end 32 of the syringe includesa rim 38 extending therefrom. The syringe is preferably pre-filled withthe substance such as a drug, vaccine or the like to be delivered priorto inserting the syringe into the holder 24.

A stopper 40 is slidably positioned in fluid-tight engagement inside thebarrel 30. A sealing or tip cap 42 may be fitted over the tip 36 toprevent the loss of fluid through the orifice prior to use of theassembly.

A spray nozzle 50 extends outwardly from the tip portion of the barreland includes a conduit therethrough in fluid communication with theorifice. The spray nozzle includes a distal end having a spray aperturein fluid communication with the conduit. It will be apparent to oneskilled in the art that there are numerous constructions that can beused to form the spray nozzle and that the arrangement described hereinis exemplary of these many possibilities. Also, it is within the purviewof this invention to include a valve-less nozzle. Accordingly, thepreferred spray nozzle is taught in the prior art and commerciallyavailable such as for example from SOFAB of Paris, France and taught inSOFAB's French Patent No. 2,635,084, the disclosure of which is herebyincorporated by reference in its entirety.

Referring to FIGS. 3 and 4, the two portions 26, 28 of the holder 24 areergonomically shaped to facilitate handling and preferably have agenerally tubular configuration to accommodate the syringe. In addition,the two portions 26, 28 are preferably made from a plastic material suchas polypropylene. The distal portion 26 includes an elongated body 26Ahaving a first, enlarged end 60 through which the tip 36, tip cap 42 andspray nozzle 50 can extend, and a second, opened end 62 defining anopening of sufficient size for receiving the syringe barrel, but whichis preferably equal in size than the rim 38 through which the syringemay be inserted into the distal portion of the holder. In this way,preferably, the syringe is securely retained in the distal portion ofthe holder by a pair of grooves 64 and detents 66 as shown in FIGS.10-12, situated proximally to the open end and dimensioned so that therim of the syringe may extend therefrom. To facilitate insertion of therim past the detents, as well as inhibit removal of the syringe from theholder, a projection to form the detent 66, as well as the groove, issituated adjacent each groove for retaining the syringe in the distalportion 26 of the holder 24 (FIGS. 10-12). Each detent 66 includesangled end face 70 and a shoulder portion 72 defined by the innersurface of the detent which allows the rim of the syringe to snap behindthe detents and lock the rim of the syringe in place.

In addition, a pair of flanges 74 extending radially outwardly from thefirst end 60 towards the second open end 62 and are attached therealongby a plurality of ribs 76 (FIG. 4). The front end 60 is larger indiameter than the diameter of an average adult nostril, and is blunt.While the embodiment shown in the drawings has a front end face which isrounded, it may alternatively be oval or any other shape desired,provided that the front end face is prevented from entry into thenostril.

One or more windows 78 are provided in the body 26A of the distalportion of the holder (FIG. 4). The windows may be in the form ofopenings in the body, or transparent wall portions mounted to the body.The windows allow the user to view the syringe barrel located within theholder. The user can accordingly determine whether there is anysubstance present in the syringe, and whether the substance is suitablefor administration. As some pharmaceutical products are frozen duringstorage, it may be important to determine whether the product within thesyringe has thawed prior to administration.

The proximal portion 28 of the holder is designed to be assembled to thedistal portion 26 and preferably acts as a plunger rod during activationof the system. In addition, the proximal portion includes a means forcontrolling delivery of the substance, as well as to divide thesubstance into at least two doses. Specifically, the proximal portionincludes an end face defining an opening 80 of sufficient size foraccommodating at least a portion of the body 26A of the distal portion26 of the holder. In the preferred embodiment, the other end 82 isclosed and includes an elongated rod 84 integrally formed in theproximal portion of the holder and extending from the closed end 82towards the open end 80. The rod 84 is of a sufficient size anddimension to engage the stopper during activation of the system.However, it should be appreciated that a conventional plunger rod may beutilized with the syringe instead of having an integrally formed rod 84in the holder.

Referring to FIGS. 3-9, the means utilized to control delivery of thesubstance includes a plurality of slots extending axially along the bodyof the proximal portion of the holder. The slots are preferably providedin two corresponding sets situated on each side thereof. Specifically,each set includes a first slot 90 and a second slot 92 extending axiallyalong the body of the proximal portion of the holder generally parallelto each other. The slots are dimensioned and situated about the body 28Aof the proximal portion 28 of the holder to accommodate the ribs 76connecting the flanges 74 to the body 26A of the distal portion 26 sothat the ribs are insertable into the slots and able to travel along theslots upon activation of the system.

Referring to FIG. 5, the first slot 90 is preferably open and is dividedinto at least two portions 90A, 90B when the system is to be used todeliver at least two doses of the substance, with each portion 90A, 90Bhaving a length corresponding to the desired distance in which thestopper must travel to expel the substance from the chamber of thesyringe barrel. Situated adjacent the open end of the slot 90 is abridge 98 extending across at least a portion of the slot, andpreferably bridging the entire gap of the slot. The bridge isdimensioned so that when a rib 76 comes in contact with the bridge andsufficient force is applied there against, the bridge will fracture andallow passage of the rib along the slot. In this way, the rib willtravel along the slot until is comes in contact with a stop 100 situatedat the end of the first portion 90A of the slot 90. The second portion90B of the slot 90 is preferably slightly offset from the first portion90A of the slot and towards the other slot 92.

A detent 99 is situated adjacent the open end 80 of the proximal portionof the holder along the slot 90 so that the rib can be clipped orsnapped between the detent 99 and the bridge 98 prior to activation ofthe system.

In addition, a corresponding rib 76 travels along the other or secondslot 92 to provide structural stability and tracking, and the other slot92 includes a biasing means to bias the rib in the first slot towardsthe second portion of the slot upon releasing/relaxing of the forceapplied by the user. Specifically, the other slot 92 includes a cut-awayportion forming a deflectable arm 102 having a inner wall 104 associatedwith the slot slightly inclined and an upper portion 106 having a widthless than a lower extending portion 108 and the slot 92 being wider atan open end 109 and narrowing along the slightly inclined inner wall 104of the deflectable arm 102 (FIGS. 5 and 6). In this way, as the two ribs72 travel along their respective slots 90, 92, the one rib travelingalong slot 92 will deflect the flexible arm 102 to cause the proximalportion 28 of the holder to rotate relative to the distal portion 26about its central axis, and the rib 76 traveling along slot 90 will movealong the stop 100 and adjacent a bridge 110 similar to the first bridgebut extending across the second portion 90B of the slot before travelingalong the second portion 90B of the slot 90 (FIG. 7). Accordingly, uponsufficient force being applied, the bridge 110 will fracture to allowpassage of the rib 76 into the second portion 90B of the slot (FIG. 8)and there along until it reaches the bottom of the slot (FIG. 9). Itshould also be appreciated that the inclined inner wall may havesufficient flexibility to provide the necessary biasing to causerelative rotation.

It should be appreciated that for purposes of illustration, the devicehas been described with respect to one set of slots and ribs. However, acorresponding arrangement is preferably provided on the other side ofthe holder. Also, it should be apparent that the slot can be dividedinto successive portions to further divide the substance to be deliveredinto additional doses.

Although the system of the present invention has been described inconnection with preferably the use of a nasal syringe, it should beappreciated that the holder may also be used in connection with syringeshaving needles such as those described in U.S. Pat. No. 4,964,866(Szwarc), U.S. Pat. No. 4,986,818 (Imbert et al.) and U.S. Pat. No.5,607,400 (Thibault et al.), the disclosures of which are herebyincorporated by reference in their entirety as though fully set forthherein.

Also, it should be appreciated that although the preferred embodimenthas been described in connection with a single compartment syringe, amulti-compartment syringe (not shown) can be utilized where, forexample, a diluent is provided in one chamber and at least one dry orwet substance is provided in another chamber such as those described inU.S. Pat. No. U.S. Pat. No. 4,599,082 (Grimard), U.S. Pat. No. 4,613,326(Szwarc), U.S. Pat. No. 4,929,230 (Pfleger) and U.S. Pat. No. 4,235,235(Bekkering), the disclosures of which are hereby incorporated byreference as though fully set forth herein. In this way, the firstportion of the slot can be used to permit the stopper to travel asufficient distance so as to permit mixing of the two substances.Thereafter, travel of the stopper permits the reconstituted substance tobe delivered. Also, under such circumstances the initial bridge may beeliminated or reduced to a detent for merely attaching the two portionsof the holder together.

The syringe 22 is preferably filled with the substance to be deliveredand stoppered prior to assembly with the holder 24. In this way, theprefilled syringe can be inserted into the distal portion 26 of theholder and secured therein as a result of the rim of the syringe comingin contact with the detent 66 and in front of the grooves 64. Then theproximal portion 28 of the holder can be secured to the distal portion26 of the holder by inserting the ribs 76 of the flanges 74 into theinitial portion of each slot between the detents 99 and the bridges 98.

Operation and Use

Having described the preferred embodiment of the drug delivery system 20of the present, including the assembly thereof, its operation and use isdescribed below in connection with FIGS. 5-12, and in particular FIGS.13 and 14, with FIGS. 5 and 10 illustrating the system prior toactivation.

In operation, the user grasps the pre-assembled system 20 as shown inFIG. 13 and with the tip cap 42 removed, insert the blunt tip into onenostril. The proximal portion of the holder is then moved towards thedistal portion of the holder by the user squeezing together his thumband two forefingers so that the two portions move towards each otherwith the proximal portion acting as a plunger rod (FIGS. 5 and 6). Thismovement, causes the displacement of the stopper 40 and expulsion of apredetermined amount of the substance 112 contained in the chamber ofthe syringe barrel through the orifice 37, depending upon the distancethat the proximal portion, as well as the rod, travels until itsprogress is arrested by first stop, as shown in FIG. 11. For simplicity,the total distance that the stopper 40 may be displaced into the barrel30 of the syringe 22 is depicted by the legend “L” in FIG. 10, with thatdistance “L” also correlating to the total quantity of substanceretained in the syringe barrel. Similarly, the displacement of thestopper a distance L/n, would correlate to a first desired quantity ofthe substance to be administered from the syringe during a first motionof the proximal portion. For instance, for an application to a nasalsyringe, it is typically desirable to ensure equal administration of thesubstance into each of the nostrils, meaning that it would be desirableto expel only half of the contents of the syringe at such time as therib is arrested by the first stop (thus, L/n would correlate to L/2).

After a first administration of the substance, then the user wouldremove the system 20 from that nostril and place it in the other nostril(FIG. 14), naturally relaxing the pressure or force being applied to thesystem resulting in the proximal portion of the holder rotating aboutits axis by the force exerted by the flexible arm so as to put the ribin position to travel along the second portion of the slot adjacent thesecond bridge (FIG. 7). Once the rib is so situated and the systemsituated in the other nostril, the proximal portion of the holder isagain squeezed, causing the rod to advance and fracture bridge 110 (FIG.8) and engage the stopper to expel the remaining contents of the syringeinto the other nostril. FIGS. 9 and 12 show the system 20 once thecontents have been expelled. Once so used, the entire system istypically discarded.

The system 20 provides a number of advantageous features. It allows theuser to easily divide the dose to be delivered from the syringe usingonly one hand to position and activate the system. When used with anasal syringe, the enlarged end of the holder limits the penetration ofthe syringe tip into the nostril. In addition the overall configurationof the holder together with its enlarged flanges facilitates itshandling and use with only one hand.

As illustrated in FIG. 15, in the alternative, the syringe may beretained in the distal portion of the holder by a pair of detents or agroove 200 running along the tip in which a corresponding rim on thespray nozzle can be inserted.

While the preferred embodiment of the present invention has beendescribed so as to enable one skilled in the art to practice the deviceof the present invention, it is to be understood that variations andmodifications may be employed without departing from the concept andintent of the present invention as defined in the following claims. Thepreceding description is intended to be exemplary and should not be usedto limit the scope of the invention. The scope of the invention shouldbe determined only by reference to the following claims.

What is claimed is:
 1. A method of intranasally delivering at least onesubstance in at least two doses, comprising the steps of: grasping apre-assembled drug delivery system with a thumb and two forefingers ofone hand, said drug delivery system including a drug container and aholder, with the drug container including a barrel, a first endextending from the barrel, and a stopper slidably positioned within thebarrel and the holder having a distal portion and a proximal portion,with the distal portion being assembled to the proximal portion, withthe drug container secured therein, and the proximal portion acting as aplunger rod during activation of the system; inserting an end of saiddrug container into a first nostril of a person to whom the substance isto be intranasally delivered; squeezing together the thumb and twoforefingers of the one hand to apply sufficient force to break a firstfrangible bridge extending across a slot to insure the application of aminimum force; moving the proximal portion of the holder towards thedistal portion of the holder a first predetermined distance during afirst motion as a result of continuing to squeeze together the thumb andtwo forefingers to cause a first displacement of the stopper andexpulsion of a first predetermined amount of a substance contained inthe chamber of the drug container barrel into said first nostril;removing the end of said drug container from said first nostril whilerelaxing the squeezing force being applied and inserting the end of saiddrug container into a second nostril of the person to whom the substanceis to be intranasally delivered; squeezing together the thumb and twoforefingers to apply sufficient force to break a second frangible bridgeextending across the slot to insure application of a minimum force; andmoving the proximal portion of the holder towards the distal portion ofthe holder a second predetermined distance during a second motion as aresult of continuing to squeeze together the thumb and two forefingersto cause a second displacement of the stopper and expulsion of a secondpredetermined amount of the substance contained in the chamber of thedrug container barrel into said second nostril.
 2. The method describedin claim 1 wherein said first predetermined distance is approximatelyequal to said second predetermined distance and said first predeterminedamount of substance expelled is approximately equal to said secondpredetermined amount of substance expelled.
 3. The method described inclaim 1, further comprising the step of visually inspecting thesubstance in the drug container located within the holder through atleast one window located in said distal portion of said holder.
 4. Themethod described in claim 1, wherein relaxing the force being appliedduring said first motion causes the proximal portion of the holder torotate about a longitudinal axis by a force exerted by biasing means. 5.The method described in claim 1, wherein the step of grasping the drugdelivery includes placing each of the two forefingers on a flangeextending from the distal portion of the holder and placing the thumb ona closed end of the proximal portion of the holder.
 6. The methoddescribed in claim 1, further comprising the step of removing a tip capfrom said first end of said barrel of said drug container beforeinserting the end of said drug container into said first nostril of theperson to whom the substance is to be intranasally delivered.
 7. Asystem for delivering at least one substance in at least two doses,comprising: a drug container including an open end and a stopperslideably positioned with said container; a holder surrounding said drugcontainer including a first generally tubular body portion having anopen end and a second generally tubular body portion having an open endtelescopically received in said open end of said first generally tubularbody portion; one of said generally tubular body portions including atleast two circumferentially spaced ribs and the other of said generallytubular body portions including two generally axially extendingcircumferentially spaced slots receiving said circumferentially spacedribs including a first slot including a first axially extending slotportion adjacent said open end and a second axially extending slotportion circumferentially offset from said first axially extending slotportion; and a second slot of said generally axially extendingcircumferentially spaced slots including a deflectable side wallextending into said second slot generally circumferentially aligned withan intersection of said first and second axially extending slot portionsof said first slot, said deflectable side wall rotating said other ofsaid generally tubular body portions to align said rib in said firstaxially extending slot portion with said second axially extending slotportion when said rib in said second slot is generally circumferentiallyaligned with said intersection of said first and second axiallyextending slot portions.
 8. The system as defined in claim 7, whereinsaid deflectable side wall of said second slot is formed by adeflectable arm having a first end portion integral with said other ofsaid generally tubular body portions and a second free end portionextending into said second slot.
 9. The system as defined in claim 7,wherein said intersection of said first and second axially extendingslot portions of said first slot includes an integral frangible bridgeportion at said intersection.
 10. The system as defined in claim 7,wherein said first slot includes an opening through said open end ofsaid other of said generally tubular body portions and an integralfrangible bridge portion located between said opening through said openend of said other of said generally tubular body portions and said firstaxially extending slot portion.
 11. A system for delivering at least onesubstance in at least two doses, comprising: a drug container includingan open end and a stopper slideably positioned within said container; aholder surrounding said drug container including a first generallytubular body portion having an open end and a second generally tubularbody portion having an open end telescopically received in said open endof said first generally tubular body portions; one of said generallytubular body portions including at least two circumferentially spacedribs and the other of said generally tubular body portions including twogenerally axially extending circumferentially spaced slots receivingsaid circumferentially spaced ribs including a first slot having anopening through said open end of said other of said generally tubularbody portions, a first axially extending slot portion adjacent saidopening and a second axially extending slot portion circumferentiallyoffset from said first axially extending slot portion; and an integralfrangible bridge portion extending between said opening through saidopen end of said other of said generally tubular body portions and saidfirst axially extending slot portion.
 12. The system as defined in claim11, wherein a second slot of said generally axially extendingcircumferentially spaced slots includes a deflectable side wallextending into said second slot generally circumferentially aligned withan intersection between said first and second axially extending slotportions of said first slot, said deflectable side wall rotating saidother of said generally tubular body portions to align said rib withsaid second axially extending slot portion when said rib is located insaid second slot, said deflectable side wall generally circumferentiallyaligned with said intersection of said first and second axiallyextending slot portions.
 13. The system as defined in claim 11, whereinsaid intersection of said first an second axially extending slotportions of said first slot includes an integral frangible bridgeportion.
 14. A method of intranasally delivering at least one substancein at least two doses, comprising the following steps: grasping apre-assembled drug delivery system with a thumb and forefingers, saiddrug delivery system including a drug container and a holder, with saiddrug container including an open end, a stopper slideably received inthe container and a drug in the drug container between the stopper andthe open end, and said holder surrounding said drug container includinga first body portion telescopically received in a second body portionand telescopic movement of the second body portion into the first bodyportion drives said stopper toward said open end upon actuation of thesystem, said first body portion including a radial rib and said secondbody portion including a generally axially extending slot receiving saidrib including a first slot portion and a second slot portioncircumferentially offset from said first slot portion; inserting saidopen end of said drug container in a first nostril of a person to whomsaid drug is to be intranasally delivered; applying a squeezing force bysqueezing together said first and second body portions of said holder todrive said rib through said first slot portion, driving said stoppertoward said open end of said container a predetermined distance equal tothe length of said first slot portion to deliver a first dose of saiddrug into said first nostril; removing said open end of said drugcontainer from said first nostril while relaxing said squeezing forceapplied to said first and second body portions; said first and secondbody portions then relatively rotating without manual manipulation toreceive said radial rib opposite said second slot portion; insertingsaid open end of said drug container in a second nostril of the personto whom said drug is to be intranasally delivered; and squeezingtogether said first and second body portions of said holder to drivesaid stopper toward said open end of said container a distance equal tosaid second slot portion to deliver a second dose of said drug to saidsecond nostril.
 15. The method as defined in claim 14, wherein said slotincludes an opening receiving said rib and a first integral frangiblebridge located between said opening and said first slot portion, whereinsaid method includes squeezing together said first and second bodyportions with sufficient force to break said first integral frangiblebridge to receive said rib in said first slot portion.
 16. The method asdefined in claim 14, wherein said generally axially extending slotincludes a second integral frangible bridge located between said firstand second slot portions, wherein said method includes squeezingtogether said first and second body portions with sufficient force tobreak said second integral frangible bridge to receive said rib in saidsecond slot portion.